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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000509-29 | EudraCT Number | ||
| 2023-508529-29-00 | EU Trial (CTIS) Number | ||
| RECF-005058 | Registry Identifier | National Institute of Cancer France |
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After reviewing all available data from Part 1 of the trial, the Sponsor has decided not to proceed to Part 2 (randomized Phase 2) of the trial due to lack of efficacy
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| Name | Class |
|---|---|
| BioNTech SE | INDUSTRY |
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The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors.
The study will be conducted in two parts: Part 1 (dose-finding) and Part 2 (randomization).
Part 1 will evaluate the safety of immunoradiotherapy combinations and establish the dose(s) to be evaluated in Part 2.
Part 2 will evaluate the anti-tumor activity of immunoradiotherapy combinations at the established dose(s) from Part 1.
Participants in both parts are treated with one of the following combinations:
While participants in Part 1 are assigned sequentially (GEN1042 without pembrolizumab is investigated first), participants in Part 2 are randomized 1:1 in the two treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy + GEN1042 | Experimental |
| |
| Radiotherapy + GEN1042 + Pembrolizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEN1042 | Biological | Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | A DLT was defined as any grade 5 toxicity, treatment-related toxicity that caused the participant to discontinue treatment during Cycle 1, febrile neutropenia grade 3 or grade 4, grade 3 thrombocytopenia associated with clinically significant bleeding, grade 4 thrombocytopenia of any duration, grade 4 anemia, any grade ≥3 non-hematologic clinical (non-laboratory) toxicity with exceptions per protocol, any grade 3 or grade 4 non-hematologic laboratory value if clinically significant medical intervention was required to treat the participant or the abnormality led to hospitalization, or the abnormality persisted for >7 days, and the abnormality resulted in a drug-induced liver injury (DILI) as defined by Hy's Law. Toxicities were graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0). | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST) v1.1 as assessed by investigator. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 millimeters (mm) in all pathological target and non-target lesions. PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Official | Genmab | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Leon Berard | Lyon | 69008 | France | |||
| Institut Gustave Roussy |
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This trial was planned to be conducted in two parts, Part 1 and Part 2. The trial was terminated early after Part 1 (27 Gy Cohorts). Part 2 was not initiated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 Cohort 1: 27Gy Stereotactic Body Radiotherapy (SBRT) + GEN1042 | Participants received 27Gy SBRT and 100 milligrams (mg) GEN1042 via intravenous (IV) infusion every 3 weeks. |
| FG001 | Part 1 Cohort 2: 27Gy SBRT + GEN1042 + Pembrolizumab | Participants received 27Gy SBRT, 100mg GEN1042 and 200mg pembrolizumab via IV infusion every 3 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab).
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 Cohort 1: 27Gy SBRT + GEN1042 | Participants received 27Gy SBRT and 100 mg GEN1042 via IV infusion every 3 weeks. |
| BG001 | Part 1 Cohort 2: 27Gy SBRT + GEN1042 + Pembrolizumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | A DLT was defined as any grade 5 toxicity, treatment-related toxicity that caused the participant to discontinue treatment during Cycle 1, febrile neutropenia grade 3 or grade 4, grade 3 thrombocytopenia associated with clinically significant bleeding, grade 4 thrombocytopenia of any duration, grade 4 anemia, any grade ≥3 non-hematologic clinical (non-laboratory) toxicity with exceptions per protocol, any grade 3 or grade 4 non-hematologic laboratory value if clinically significant medical intervention was required to treat the participant or the abnormality led to hospitalization, or the abnormality persisted for >7 days, and the abnormality resulted in a drug-induced liver injury (DILI) as defined by Hy's Law. Toxicities were graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0). | Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab). | Posted | Count of Participants | Participants | 21 days |
|
Up to approximately 2 years 5 months
Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 Cohort 1: 27Gy SBRT + GEN1042 | Participants received 27Gy SBRT and 100 mg GEN1042 via IV infusion every 3 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ataxia | Nervous system disorders | 26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
After reviewing all available data from Part 1 of the trial, the Sponsor decided not to proceed to Part 2 (randomized Phase 2) of the trial due to lack of efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CLINICAL TRIAL INFORMATION | Genmab | +45 7020 2728 | clinicaltrials@genmab.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2024 | Jun 29, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Part 1 is sequential, Part 2 is parallel (randomized)
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| Pembrolizumab | Drug | Intravenous |
|
| Radiotherapy | Radiation | Radiotherapy |
|
| Up to approximately 2 years 5 months |
| Duration of Response (DOR) | DOR was defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by investigator. | Up to approximately 2 years 5 months |
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants with BOR of CR, PR, and stable disease (SD) according to RECIST v1.1 as assessed by investigator. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 millimeters (mm) in all pathological target and non-target lesions. PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). | Up to approximately 2 years 5 months |
| Progression Free Survival (PFS) | PFS was defined as the time from the date of randomization (or date of first administration of GEN1042 ± pembrolizumab treatment for participants in Part 1) to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by investigator. | Up to approximately 2 years 5 months |
| Overall Survival (OS) | OS was defined as the time from date of randomization (or date of first administration of GEN1042 ± pembrolizumab treatment for participants in Part 1) to date of death due to any cause. | Up to approximately 2 years 5 months |
| Number of Participants With Abscopal Response in Non-irradiated Target Lesions As Assessed by the Investigator | An abscopal response described radiotherapy (RT)-induced immune-mediated tumor regression at sites distant to the irradiated field. For the purpose of this trial, an abscopal response was defined as a reduction of at least 30% in diameter of the best responding unirradiated target lesion. Data are reported for the number of participants with abscopal response in non-irradiated target lesions as assessed by the investigator. | Up to approximately 2 years 5 months |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE was any AE that occurred or worsened after the first dose of trial treatment. A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section. | Up to approximately 2 years 5 months |
| Blood Concentration of GEN1042 Over Time | Blood samples were collected for measurement of serum concentrations of GEN1042. Data are reported for Cycle (C)1 Day (D)1 pre-dose and end of infusion (EOI), C1D8, C1D15, C2D1 pre-dose and end of infusion, C2D8, C2D15, C3D1 pre-dose and end of infusion,C4D1 pre-dose and end of infusion,C4D8, C5D1 pre-dose and end of infusion, C7D1 pre-dose and end of infusion,C11D1 end of infusion,C12D1 end of infusion+2 hours,C15D1 end of infusion,C19D1 end of infusion,C23D1 end of infusion, End of Treatment (~D487) and Safety Follow Up (~D517). Cycles were 21 days in length. | At multiple timepoints (as described in the "Outcome Measure Description" field between Cycle 1 Day 1 up to Safety Follow Up [up to approximately Day 517]). Cycles were 21 days in length. |
| Number of Participants With Anti-drug Antibodies (ADAs) | Venous blood samples were drawn for analysis of ADAs. Data are reported for the number of participants with an on-treatment ADA status of positive. For on-treatment results, a participant was considered ADA positive if either 1) ADA was negative at baseline and at least one on-treatment result was positive 2) positive at baseline and at least one positive on-treatment result with at least one titer higher than baseline. | Up to approximately 2 years 5 months |
| Villejuif |
| 94805 |
| France |
| Withdrawal by Subject |
|
Participants received 27Gy SBRT, 100mg GEN1042 and 200mg pembrolizumab via IV infusion every 3 weeks.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Part 1 Cohort 1: 27Gy Stereotactic Body Radiotherapy (SBRT) + GEN1042 | Participants received 27Gy SBRT and 100 milligrams (mg) GEN1042 via intravenous (IV) infusion every 3 weeks. |
| OG001 | Part 1 Cohort 2: 27Gy SBRT + GEN1042 + Pembrolizumab | Participants received 27Gy SBRT, 100mg GEN1042 and 200mg pembrolizumab via IV infusion every 3 weeks. |
|
|
| Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST) v1.1 as assessed by investigator. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 millimeters (mm) in all pathological target and non-target lesions. PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab). | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 2 years 5 months |
|
|
|
| Secondary | Duration of Response (DOR) | DOR was defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by investigator. | Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab). Measured in participants with a BOR of CR or PR. | Posted | Median | 95% Confidence Interval | months | Up to approximately 2 years 5 months |
|
|
|
| Secondary | Disease Control Rate (DCR) | DCR was defined as the percentage of participants with BOR of CR, PR, and stable disease (SD) according to RECIST v1.1 as assessed by investigator. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 millimeters (mm) in all pathological target and non-target lesions. PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). | Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab). | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 2 years 5 months |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from the date of randomization (or date of first administration of GEN1042 ± pembrolizumab treatment for participants in Part 1) to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by investigator. | Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab). | Posted | Median | 95% Confidence Interval | months | Up to approximately 2 years 5 months |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from date of randomization (or date of first administration of GEN1042 ± pembrolizumab treatment for participants in Part 1) to date of death due to any cause. | Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab). | Posted | Median | 95% Confidence Interval | months | Up to approximately 2 years 5 months |
|
|
|
| Secondary | Number of Participants With Abscopal Response in Non-irradiated Target Lesions As Assessed by the Investigator | An abscopal response described radiotherapy (RT)-induced immune-mediated tumor regression at sites distant to the irradiated field. For the purpose of this trial, an abscopal response was defined as a reduction of at least 30% in diameter of the best responding unirradiated target lesion. Data are reported for the number of participants with abscopal response in non-irradiated target lesions as assessed by the investigator. | Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab). | Posted | Count of Participants | Participants | Up to approximately 2 years 5 months |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE was any AE that occurred or worsened after the first dose of trial treatment. A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section. | Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab). | Posted | Count of Participants | Participants | Up to approximately 2 years 5 months |
|
|
|
| Secondary | Blood Concentration of GEN1042 Over Time | Blood samples were collected for measurement of serum concentrations of GEN1042. Data are reported for Cycle (C)1 Day (D)1 pre-dose and end of infusion (EOI), C1D8, C1D15, C2D1 pre-dose and end of infusion, C2D8, C2D15, C3D1 pre-dose and end of infusion,C4D1 pre-dose and end of infusion,C4D8, C5D1 pre-dose and end of infusion, C7D1 pre-dose and end of infusion,C11D1 end of infusion,C12D1 end of infusion+2 hours,C15D1 end of infusion,C19D1 end of infusion,C23D1 end of infusion, End of Treatment (~D487) and Safety Follow Up (~D517). Cycles were 21 days in length. | Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab). Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = number of participants evaluable at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | At multiple timepoints (as described in the "Outcome Measure Description" field between Cycle 1 Day 1 up to Safety Follow Up [up to approximately Day 517]). Cycles were 21 days in length. |
|
|
|
| Secondary | Number of Participants With Anti-drug Antibodies (ADAs) | Venous blood samples were drawn for analysis of ADAs. Data are reported for the number of participants with an on-treatment ADA status of positive. For on-treatment results, a participant was considered ADA positive if either 1) ADA was negative at baseline and at least one on-treatment result was positive 2) positive at baseline and at least one positive on-treatment result with at least one titer higher than baseline. | Full Analysis Set included all participants enrolled and treated with at least 1 dose of trial treatment (GEN1042 ± pembrolizumab). | Posted | Count of Participants | Participants | Up to approximately 2 years 5 months |
|
|
|
| 4 |
| 6 |
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | Part 1 Cohort 2: 27Gy SBRT + GEN1042 + Pembrolizumab | Participants received 27Gy SBRT, 100mg GEN1042 and 200mg pembrolizumab via IV infusion every 3 weeks. | 3 | 7 | 2 | 7 | 7 | 7 |
| Diabetes mellitus | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | 26.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | 26.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | 26.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | 26.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | 26.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Pain | General disorders | 26.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | 26.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | 26.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | 26.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | 26.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | 26.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | 26.1 | Systematic Assessment |
|
| Fatigue | General disorders | 26.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
|
| Blood creatine increased | Investigations | 26.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | 26.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
|
| Salivary hyposecretion | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | 26.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | 26.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | 26.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | 26.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Asthenia | General disorders | 26.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | 26.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | 26.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | 26.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | 26.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | 26.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 26.1 | Systematic Assessment |
|
| Vulvovaginal burning sensation | Reproductive system and breast disorders | 26.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
|
| Chills | General disorders | 26.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | 26.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | 26.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 26.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | 26.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | 26.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | 26.1 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 26.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | 26.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 26.1 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | 26.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
|
Not provided
Not provided
| C1D1 EOI |
|
|
| C1D8 |
|
|
| C1D15 |
|
|
| C2D1 Pre-dose |
|
|
| C2D1 EOI |
|
|
| C2D8 |
|
|
| C2D15 |
|
|
| C3D1 Pre-dose |
|
|
| C3D1 EOI |
|
|
| C4D1 Pre-dose |
|
|
| C4D1 EOI |
|
|
| C4D8 |
|
|
| C5D1 Pre-dose |
|
|
| C5D1 EOI |
|
|
| C7D1 Pre-dose |
|
|
| C7D1 EOI |
|
|
| C11D1 EOI |
|
|
| C12D1 EOI + 2 Hours |
|
|
| C15D1 EOI |
|
|
| C19D1 EOI |
|
|
| C23D1 EOI |
|
|
| End of Treatment (~D487) |
|
|
| Safety Follow Up (~D517) |
|
|